Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With Pulmonary Arterial Hypertension (PAH)
This study has been completed.
Sponsor:
Actelion
Information provided by:
Actelion
ClinicalTrials.gov Identifier:
NCT00086463
First received: July 1, 2004
Last updated: March 31, 2011
Last verified: March 2011
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Purpose
The purpose of this study is to determine the safety and efficacy of Iloprost in subjects that have Pulmonary Arterial Hypertension who are concurrently taking bosentan (Tracleer TM).
| Condition | Intervention | Phase |
|---|---|---|
|
Pulmonary Arterial Hypertension Ayerza Syndrome Pulmonary Hypertension |
Drug: Iloprost or placebo |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Double-Blind Primary Purpose: Treatment |
| Official Title: | A Safety and Pilot Efficacy Trial of Iloprost Inhaled Solution as Add-On Therapy With Bosentan in Subjects With PAH |
Resource links provided by NLM:
Further study details as provided by Actelion:
| Estimated Enrollment: | 60 |
| Study Start Date: | June 2004 |
| Study Completion Date: | January 2006 |
| Primary Completion Date: | January 2006 (Final data collection date for primary outcome measure) |
This is a randomized, placebo-controlled study in subjects with Pulmonary Arterial Hypertension (PAH) with an NYHA Class of III or IV who are receiving conventional therapy and bosentan. Subjects who fulfill the inclusion and exclusion criteria will be randomized to study drug (active or placebo) at a frequency of 6-9 inhalations per day for 12 weeks and will continue conventional therapy and bosentan. At the end of the double-blind phase study, open label Iloprost will be provided.
Eligibility| Ages Eligible for Study: | 12 Years to 75 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- Diagnosis of PAH due to PPH, connective tissue disease, HIV, or repaired (≥ 1 year) ASD, VSD, or PDA
- NYHA Functional Class III or IV
- On bosentan for at least 16 weeks, with the dose stable (maximum dose 125 mg BID) for at least 8 weeks
- Age 12-75 years, of either gender
- Six minute walk distance 100-425 meters at Baseline
Exclusion Criteria:
- Any new long-term treatment for PAH added within the last 4 weeks
- Any therapy with a PDE (phosphodiesterase), L -arginine or a prostaglandin, concurrently, or within the last 4 weeks
- PAH related to chronic thromboembolic disease, portopulmonary disease, or any etiology other than PPH, connective tissue disease, HIV, or repaired ASD, VSD, or PDA
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00086463
Locations
| United States, Alabama | |
| University of Alabama at Birmingham | |
| Birmingham, Alabama, United States, 35294 | |
| United States, California | |
| UCSD Medical Center | |
| La Jolla, California, United States, 92037 | |
| Stanford University Medical Center | |
| Palo Alto, California, United States, 94305 | |
| UCSF Medical Center | |
| San Francisco, California, United States, 94143 | |
| Harbor-UCLA Medical Center | |
| Torrance, California, United States, 90502 | |
| United States, Colorado | |
| University of Colorado HSC | |
| Denver, Colorado, United States, 80262 | |
| The Children's Hospital | |
| Denver, Colorado, United States, 80218 | |
| United States, Illinois | |
| Rush Heart Institute, Center for Pulmonary Heart Disease | |
| Chicago, Illinois, United States, 60612 | |
| United States, Maryland | |
| Johns Hopkins University | |
| Baltimore, Maryland, United States, 21205 | |
| United States, Michigan | |
| University of Michigan | |
| Ann Arbor, Michigan, United States, 48109 | |
| United States, Minnesota | |
| Mayo Clinic | |
| Rochester, Minnesota, United States, 55095 | |
| United States, New York | |
| Columbia University Medical Center | |
| New York, New York, United States, 10032 | |
| United States, North Carolina | |
| Duke University Medical Center | |
| Durham, North Carolina, United States, 27710 | |
| United States, Pennsylvania | |
| University of Pittsburgh | |
| Pittsburgh, Pennsylvania, United States, 15213 | |
| United States, Tennessee | |
| Vanderbilt University Medical Center | |
| Nashville, Tennessee, United States, 37232 | |
| United States, Texas | |
| Baylor College of Medicine | |
| Houston, Texas, United States, 77030 | |
| United States, Utah | |
| Latter Day Saints Hospital | |
| Salt Lake City, Utah, United States, 84143 | |
Sponsors and Collaborators
Actelion
Investigators
| Study Director: | Henry Hsu, M.D. | CoTherix |
More Information
Publications:
| ClinicalTrials.gov Identifier: | NCT00086463 History of Changes |
| Other Study ID Numbers: | STEP STUDY, STEP, Pulmonary Hypertension, Pulmonary Artery, Cotherix |
| Study First Received: | July 1, 2004 |
| Last Updated: | March 31, 2011 |
| Health Authority: | United States: Food and Drug Administration |
Keywords provided by Actelion:
|
STEP PAH iloprost inhalation prostacyclin |
Additional relevant MeSH terms:
|
Hypertension, Pulmonary Hypertension Lung Diseases Respiratory Tract Diseases Vascular Diseases Cardiovascular Diseases Iloprost Bosentan |
Platelet Aggregation Inhibitors Hematologic Agents Therapeutic Uses Pharmacologic Actions Vasodilator Agents Cardiovascular Agents Antihypertensive Agents |
ClinicalTrials.gov processed this record on May 19, 2013